Cell-based botox batch test
Regulatory accepted CompanyNovember 2012
Allergan Inc., Irvine, USA
Botulinum neurotoxin serotype A (BoNT/A), usually referred to as Botox, is an effective therapeutic agent used to treat various diseases. It inhibits the signal transmission of nerve cells, which leads to muscle paralysis. This effect is used in the treatment of strabismus, torticollis, hyperhidrosis or bladder dysfunction, but also for aesthetic purposes such as relaxation of the facial muscles, which leads to wrinkle smoothing. Up to now, the toxin concentration of each batch was and is determined in animal tests. The so-called LD50 test determines the concentration at which 50 % of the mice in a group die. Here, an animal-experiment-free method is presented. BoNT inhibits vesicular neurotransmitter exocytosis by cleaving the protein SNAP25. The individual key steps of this reaction can be measured with CBPAs (cell-based efficacy assays). It uses differentiated human neuroblastoma cells (SiMa) and a sandwich ELISA that measures the BoNT/A-dependent intracellular increase in cleaved SNAP25. Allergan has validated this test for its products in the US, Canada and the EU, replacing the LD50 test for batch testing.
Botulinum neurotoxin serotype a specific cell-based potency assay to replace the mouse bioassay
Ester Fernández-Salas
Added on: 08-31-2021
[1] https://journals.plos.org/plosone/article/comments?id=10.1371/journal.pone.0049516
